TRANSLATIONAL AND REGULATORY CHALLENGES IN THE DEVELOPMENT OF NANOMEDICINE-ENABLED DRUG DELIVERY DEVICES

Nanomedicine-enabled drug delivery devices have emerged as a transformative platform in modern therapeutics, offering enhanced targeting, improved bioavailability, and personalized treatment strategies across multiple disease areas. Despite their immense clinical potential, the translation of nanomedicine-based systems from laboratory research to approved medical products remains a formidable challenge due to their complex physicochemical behavior, manufacturing variability, and evolving regulatory expectations. This review critically examines the major translational and regulatory barriers affecting the development of nanomedicine-enabled drug delivery devices. Key scientific issues such as nanomaterial heterogeneity, unpredictable in vivo performance, scalability, and reproducibility are discussed alongside the limitations of existing preclinical models in predicting human outcomes. Furthermore, the review highlights the regulatory complexities arising from the hybrid nature of these products, which often fall between traditional drug, device, and biologic classifications, leading to fragmented and non-harmonized global regulatory pathways. Strategies to address these challenges—including standardized characterization methods, adaptive regulatory frameworks, advanced manufacturing technologies, and early regulatory engagement—are explored. By identifying critical gaps and proposing future-oriented solutions, this review provides a comprehensive roadmap to facilitate the safe, efficient, and timely translation of nanomedicine-enabled drug delivery devices into clinical practice.